In a Law360 article, health care partner David Peloquin commented on impending guidance from the U.S. Food and Drug Administration on diversifying clinical trial participation.
Because the efficacy and safety of treatments can vary across patient groups, many drug developers and regulators seek to include more historically underrepresented populations.
David notes it would be helpful for the FDA to clarify the role of data from outside the U.S. in the diversity action plans, and if data from overseas could be used to meet enrollment targets for diverse populations.
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